Roche’s Perjeta cleared for early use in breast cancer

Breast cancer patients in the EU could get treatment with Roche’s Perjeta earlier in the course of the disease after the drug was approved for a new indication.

The European Medicines Agency (EMA) gave the green light for Perjeta (pertuzumab) to be used alongside Herceptin (trastuzumab) as a ‘neo-adjuvant’ treatment for HER2-positive breast cancer patients – in other words allowing it to be used prior to surgery.


The approval could make thousands more women eligible for treatment with the drug every year, adding to the buoyant growth for Perjeta and potentially making surgery less invasive for patients and reducing the chance that the cancer will recur.

The Perjeta regimen is the first neoadjuvant breast cancer treatment approved by in the EU based on pathological complete response (pCR) rather than survival data, according to the firm, which said the drug had been made available to patients more quickly as a result.

Updated results from the phase II NeoSphere trial reported a few weeks ago revealed that patients who received Perjeta, Herceptin and chemotherapy prior to surgery were 31 per cent less likely to experience disease worsening, recurrence or death, compared to those who received Herceptin and chemotherapy alone.

Perjeta has already been growing fast following approval of the neoadjuvant indication in the US in 2013 as well as increased take-up as a first-line therapy for advanced breast cancer that has spread, with earlier treatment extending the time patients are treated with the drug.

Sales rose 72 per cent in the first half to reach 659 million Swiss francs ($682 million) on what Roche said was ‘rising demand in both early (pre-surgical) and advanced breast cancer settings’.

The drug is particularly important to Roche because $6.7 billion blockbuster Herceptin started to lose patent protection in some markets last year, and analysts have suggested increased use earlier in the course of breast cancer could help sales top $1 billion a year.

Perjeta survived the recent cull of cancer therapies by the UK Cancer Drugs Fund (CDF), although Roche was forced to negotiate an undisclosed discount on its price to ensure it remained available via the scheme alongside its other HER2-targeting breast cancer drug Kadcyla (trastuzumab emtansine).

Both Perjeta and Kadcyla have been rejected by the National Institute for Health and Care Excellence (NICE) in draft guidance.

Every year in Europe nearly 100,000 people are diagnosed with HER2-positive breast cancer, an aggressive type of the disease that is more likely to progress than HER2-negative cancer.

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